Anastomosis instrument and method for performing same

ABSTRACT

An aortic punch for creating an aortotomy in a wall of a luminal structure. The aortic punch includes a housing having distal and proximal ends, first and second plungers, a first return spring and a cutting assembly. The first plunger is movable relative to the housing to expose a barb from the distal end of the housing for piercing and catching the wall of the luminal structure. The first return spring biases the barb proximally toward the distal end of the housing such that the barb pulls the wall of the luminal structure into contact with the cutting assembly. The present disclosure also relates to a method of forming an aortotomy in a luminal structure.

BACKGROUND

[0001] 1. Technical Field

[0002] The present disclosure relates to a surgical instrument andmethod for performing anastomosis of tubular body structures, and moreparticularly to an instrument for joining vascular tissues, for example,during coronary artery bypass graft procedures.

[0003] 2. Background of Related Art

[0004] Coronary artery disease is often characterized by lesions orocclusions in the coronary arteries which may result in inadequate bloodflow to the myocardium, or myocardial ischemia, which is typicallyresponsible for such complications as angina pectoris, necrosis ofcardiac tissue (myocardial infarction), and sudden death. In some cases,coronary artery disease may be treated by the use of drugs and/or bymodifications in behavior and diet. In other cases, dilatation ofcoronary arteries may be achieved by such procedures as angioplasty,laser ablation, atherectomy, catheterization, and intravascular stents.

[0005] For certain patients, a coronary artery bypass graft (“CABG”) isthe preferred form of treatment to relieve symptoms and the graft oftenincreases life expectancy. A CABG procedure consists of directanastomosis of a vessel segment to one or more of the coronary arteries.For example, a reversed segment of the saphenous vein may be grafted atone end to the ascending aorta as an arterial blood source and at theother end to a coronary artery at a point beyond the arterial occlusion.Alternatively, the internal mammary artery located in the thoraciccavity adjacent the sternum is likewise suitable for grafting to acoronary artery, such as the left anterior descending artery (“LAD”).

[0006] The performance of a CABG procedure typically requires access tothe heart, blood vessels and associated tissue. Access to the patient'sthoracic cavity may be achieved in an open procedure by making a largelongitudinal incision in the chest. This procedure, referred to as amedian sternotomy, requires a saw or other cutting instrument to cut thesternum to allow the two opposing halves of the rib cages to be spreadapart to expose the internal organs of the thoracic cavity.

[0007] U.S. Pat. No. 5,025,779 to Bugge discloses a retractor which isdesigned to grip opposite sternum halves and spread the thoracic cavityapart. The large opening which is created by this technique enables thesurgeon to directly visualize the surgical site and perform procedureson the affected organs. However, such procedures that involve largeincisions and substantial displacement of the rib cage are oftentraumatic to the patient with significant attendant risks. The recoveryperiod may be extensive and is often painful. Furthermore, patients forwhom coronary surgery is indicated may need to forego such surgery dueto the risks involved with gaining access to the heart.

[0008] U.S. Pat. No. 5,503,617 to Jako discloses a retractor configuredto be held by the surgeon for use in vascular or cardiac surgery toretract and hold ribs apart to allow access to the heart or a lungthrough an operating “window”. The retractor includes a rigid frame anda translation frame slideably connected to the rigid frame. Lower andupper blades are rotatably mounted to the rigid frame and thetranslation frame respectively. The “window” approach enables thesurgeon to gain access through a smaller incision and with lessdisplacement of the ribs, and consequently, less trauma to the patient.

[0009] Once access to the thoracic cavity has been achieved, surgery onthe heart may be performed. Such procedures typically require that theheartbeat be arrested while maintaining circulation throughout the restof the body. Cardioplegic fluid, such as potassium chloride (KCI) isdelivered to the blood vessels of the heart to paralyze the myocardium.As disclosed in WO 95/15715 to Sterman et al. for example, cardioplegicfluid is infused into the myocardium through the coronary arteries by acatheter inserted into the ascending aorta.

[0010] Alternatively, cardioplegic fluid is infused through the coronaryveins in a retrograde manner by a catheter positioned in the interiorjugular vein accessed at the patient's neck. Such procedures require theintroduction of multiple catheters into the blood vessels adjacent theheart, which is a complicated procedure requiring that the desiredvessels be properly located and accessed. The progression of the guidewires and catheters must be closely monitored to determine properplacement. Furthermore, the introduction of catheters form punctures inthe blood vessels that must be subsequently closed, and there is anincreased risk of trauma to the interior walls of the vessels in whichthe catheters must pass.

[0011] Alternatively, the CABG procedure may be performed while theheart is permitted to beat. Such a procedure is now commonly referred toas minimally invasive direct coronary artery bypass (MIDCAB) whenperformed through a thoracotomy (when performed through a sternotomy,the procedure is commonly called open coronary artery bypass (OP-CAB). Asurgical instrument is used to stabilize the heart and restrict bloodflow through the coronary artery during the graft procedure. Specialcare must be given to procedures performed on a beating heart, e.g.synchronizing procedures to occur at certain stages in the cardiaccycle, such as between heartbeats.

[0012] To perform a CABG procedure, the harvested vessel segment, suchas the saphenous vein, is grafted to the coronary artery by end-to-sideanastomosis. Typically, sutures are used to graft the vessel segments.However, conventional suturing is complicated by the use of minimallyinvasive procedures, such as the window approach, e.g., limited accessand reduced visibility to the surgical site may impede the surgeon'sability to manually apply sutures to a graft. Additionally, it isdifficult and time consuming to manually suture if the CABG procedure isbeing performed while the heart is beating as the suturing must besynchronized with the heart beat.

[0013] As can be appreciated, the process of manually suturing theharvested vessel segment to a coronary artery is time consuming andrequires a great deal of skill on the part of the surgeon. The resultingsutured anastomosis will also be dependent on the skills of the surgeon.In minimally invasive procedures such as in MIDCAB, the ability tosuture is even more complicated due to limited maneuverability andreduced visibility. U.S. Pat. No. 5,707,380 to Hinchliffe et al., theentire contents of which are hereby incorporated by reference, disclosesan apparatus and a procedure that enable remote anastomosis withoutpiercing of vessels during both conventional and minimally invasiveprocedures. A continuing need exists, however, for improved surgicalinstruments and methods for performing remote anastomoses during bothconventional and minimally invasive procedures.

SUMMARY

[0014] The present disclosure relates to an aortic punch for creating anaortotomy in a wall of a luminal structure. The aortic punch includes ahousing having distal and proximal ends, first and second plungers, afirst return spring and a cutting assembly. The first plunger is movablerelative to the housing to expose a barb from the distal end of thehousing for piercing and catching the wall of the luminal structure. Thefirst return spring biases the barb proximally toward the distal end ofthe housing such that the barb pulls the wall of the luminal structureinto contact with the cutting assembly. The tip of the cutting assemblyis preferably serrated to facilitate cutting of the aortotomy.

[0015] The second plunger is movable relative to the housing independentof the first plunger to rotate the cutting assembly against the wall ofthe luminal structure to create the aortotomy in the luminal structure.Preferably, the second plunger includes a rack which cooperates with acorresponding pinion disposed on a proximal end of the cutting assemblyto rotate the cutting assembly when the second plunger is moved relativeto the housing. The second plunger may include a second return springfor biasing the plunger in a proximal direction.

[0016] The cutting assembly advantageously includes at least two gearswhich cooperate with the rack to rotate the cutting assembly when thesecond plunger is moved relative to the housing. Preferably, the gearcooperate to convert linear movement of the second plunger to rotationalmovement of the cutting assembly. In one embodiment, at least one of thegears on the cutting assembly is beveled.

[0017] The present disclosure also relates to a method of forming anaortotomy in a luminal structure which includes the steps of:

[0018] providing an aortic punch having a housing which includes distaland proximal ends, a first plunger having a barb, a first return spring,and a second plunger mechanically engaged with a cutting assembly;

[0019] moving the first plunger relative to the housing to expose thebarb from the distal end of the housing

[0020] piercing the wall of the luminal structure with the barb;

[0021] releasing the first plunger such that the first return springbiases the barb proximally toward the distal end of the housing to catchthe wall of the luminal structure and pull the wall of the luminalstructure into contact with the cutting assembly; and

[0022] moving the second plunger relative to the housing independent ofthe first plunger to rotate the cutting assembly against the wall of theluminal structure to create the aortotomy in the luminal structure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Other objects and features of the present invention will becomeapparent from the following detailed description considered inconnection with the accompanied drawings. It should be understood,however, that the drawings are designed for the purpose of illustrationonly and not as a definition of the limits of the invention.

[0024] An illustrative embodiment of the subject surgical instrument andmethod are described herein with reference to the drawings wherein:

[0025]FIG. 1 is a perspective view of a surgical instrument constructedin accordance with an embodiment of the present disclosure;

[0026]FIG. 2 is an enlarged, partial perspective view of a single useloading unit (hereinafter “SULU”) constructed in accordance with apreferred embodiment of the present disclosure;

[0027]FIG. 2A is an enlarged, perspective view of the indicated area ofdetail of FIG. 2;

[0028]FIG. 3 is a perspective view of a surgical fastener which isdesigned for operative engagement with the SULU for creating vascularanastomosis between two luminal vessels;

[0029]FIG. 4 is a side view the surgical instrument of FIG. 1;

[0030]FIG. 4A is a left, side view of a handle/actuator assembly of thesurgical instrument of FIG. 1 shown without a cover plate attachedthereto;

[0031]FIG. 5 is an enlarged, perspective view of a distal end of theactuator assembly shown in a pre-loading position to receivingly engagethe SULU;

[0032]FIG. 6 is a reverse, perspective view of the SULU of FIG. 2;

[0033]FIG. 6A is a reverse, perspective view of a lower half of the SULUof FIG. 2;

[0034]FIG. 7 is a perspective view with parts separated of the SULU ofFIG. 2;

[0035]FIG. 7A is a greatly enlarged, perspective view of the indicatedarea of detail of FIG. 7;

[0036]FIG. 7B is a greatly enlarged, perspective view of the indicatedarea of detail of FIG. 7;

[0037]FIG. 7C is an enlarged, perspective view of a base portion of afirst retracting sleeve;

[0038]FIG. 7D is a greatly enlarged, perspective view of the indicatedarea of detail of FIG. 7C;

[0039]FIG. 7E is an enlarged view of a retaining ring which may beincorporated with the SULU to maintain a vascular anastomosis betweenthe two luminal vessels;

[0040]FIG. 7F is an enlarged, partial perspective view of the SULU ofFIG. 2 with the retaining ring of FIG. 7E positioned about the surgicalfastener prior to firing the SULU;

[0041]FIG. 7G is an enlarged, partial perspective view of the SULU ofFIG. 2 with the retaining ring of FIG. 7E positioned about the surgicalfastener after firing the SULU;

[0042]FIG. 7H is cross section of the two luminal vessels showing theposition of the retaining ring of FIG. 7E relative to a surgicalfastener after firing the SULU;

[0043]FIG. 71 is an enlarged, internal view of the two luminal vesselsshowing the position of the retaining ring of FIG. 7E relative to asurgical fastener after firing the SULU;

[0044]FIG. 7J is an enlarged view of an alternate embodiment of theretaining ring which may be incorporated with the SULU to maintain thevascular anastomosis between the two luminal vessels;

[0045]FIG. 7K is an enlarged view of the area of detail of FIG. 7Jshowing a slit formed along an inner periphery of one of the aperturesof the ring;

[0046]FIG. 7L is an enlarged view of another alternate embodiment of theretaining ring which straightens after firing the SULU;

[0047]FIG. 7M is an enlarged view of another alternate embodiment of aretaining ring which is constructed of a thin wire-like material;

[0048] FIGS. 7N-7S shows an alternate embodiment of the surgicalfastener of FIG. 3 having a protuberance extending from a base legthereof;

[0049]FIG. 8 is a greatly enlarged, perspective view of the indicatedarea of detail of FIG. 7;

[0050]FIG. 9 is a greatly enlarged, perspective view of the indicatedarea of detail of FIG. 7;

[0051]FIG. 10 is a perspective view of the actuator assembly with thecover plate shown separated;

[0052]FIG. 11 is a perspective view the actuator assembly of FIG. 10shown with parts separated;

[0053]FIG. 12 is a horizontal cross-sectional view of the surgicalinstrument of FIG. 1 shown loaded for firing;

[0054]FIG. 13 is a horizontal cross-sectional view of the indicated areaof detail of FIG. 12;

[0055]FIG. 13A is a greatly enlarged horizontal cross sectional view ofthe area indicated in detail of FIG. 13;

[0056]FIG. 14 is a top cross-sectional view of the surgical instrumenttaken along section line 14-14 of FIG. 12;

[0057]FIG. 15 is a greatly enlarged top cross-sectional view of the areaindicated in detail of FIG. 14;

[0058]FIG. 16 is a front cross-sectional view of the surgical instrumenttaken along section line 16-16 of FIG. 12;

[0059]FIG. 17 is a perspective view of the SULU with a first vesselinserted therethrough;

[0060]FIG. 18 is perspective of the SULU with an end of the first vesseleverted over a distal end of the disposable unit being inserted into anincision in a second vessel;

[0061]FIG. 19 is an internal, perspective view of the second vessel withthe SULU and the everted first vessel shown inserted therein;

[0062]FIG. 20 is a side cross-sectional view of the SULU and the evertedfirst vessel shown inserted within the second vessel in pre-firingposition;

[0063]FIG. 21 is a side view of the actuator assembly without the coverplate during a first firing stage of the instrument and showing theinternal movement of a first retractor within the actuator assembly;

[0064]FIG. 21A is a side cross-sectional view showing the relevantpositions of the internal working components of the actuator assemblyafter the first firing stage;

[0065]FIG. 21B is a side cross-sectional view showing the movement ofthe SULU during the first firing stage to deform the surgical fasteners;

[0066]FIG. 21C is a greatly enlarged side cross-sectional view of thearea indicated in detail in FIG. 21B;

[0067]FIG. 21D is a greatly enlarged perspective view of the surgicalfastener shown in a “stapled” configuration;

[0068]FIG. 21E is a side view showing the relevant movement of a lockingsleeve after the first firing stage;

[0069]FIG. 22 is a side cross-sectional view of the actuator assemblyduring the second firing stage and showing the internal movement of asecond retractor within the actuator assembly;

[0070]FIG. 22A is a side cross-sectional view of the SULU during thesecond firing stage and showing the movement of a second retractingsleeve which moves as a direct result of the movement of the secondretractor to release the surgical fasteners;

[0071]FIG. 22B is a greatly enlarged side cross-sectional view showingthe retracting movement of a finger-like retention prong which moves asa direct result the movement of the second retractor;

[0072]FIG. 23 is a perspective view of the SULU showing the pivotablemovement of the two supports which open after firing to release thefirst vessel;

[0073]FIG. 24 is a view showing a completed anastomosis;

[0074]FIG. 25 is a view showing an operating “window” with the patient'sheart exposed;

[0075]FIG. 26A is a view showing the surgical fastener staple pattern ofthe instrument described with respect to FIGS. 1-26;

[0076]FIG. 26B is a view showing one possible alternative surgicalfastener staple pattern;

[0077] FIGS. 27-30 are schematic illustrations depicting a method ofcreating an anastomosis according to the present disclosure;

[0078]FIG. 31 is a perspective view of an aortic punch for creating anaortotomy in an aortic vessel according to the present disclosure;

[0079]FIG. 32A is a right, perspective view with parts separated of theaortic punch of FIG. 31;

[0080]FIG. 32B is a left, perspective view with parts separated of theaortic punch of FIG. 31;

[0081]FIG. 33 is a side, cross-sectional view of another embodiment ofthe aortic punch according to the present disclosure; and

[0082]FIG. 34 is an enlarged perspective view of the aortic punch withparts separated.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0083] Preferred embodiments of the surgical instrument and methoddisclosed herein will be described in terms of a coronary artery bypassprocedure wherein a vascular anastomosis is created by joining a sectionof a harvested vessel, e.g., the saphenous vein, to bypass an occlusionin a coronary artery, e.g., the left anterior descending artery (“LAD”).Alternatively, the presently disclosed surgical instrument may also beutilized in performing anastomosis of other tubular luminal bodystructures.

[0084] In the drawings and in the description which follows, the term“proximal”, as is traditional, will refer to the end of the apparatuswhich is closer to the user, while the term “distal” will refer to theend which is further from the user.

[0085] Referring now in detail to the drawing figures in which likereference numerals identify similar or identical elements, oneembodiment of the present disclosure is illustrated generally in FIG. 1and is designated therein as surgical instrument 10. Surgical instrument10 includes two principal components, namely, an actuator assembly 20and a disposable loading unit (“DLU”) or a single use loading unit(“SULU”) 100, which along with their internal working components,mechanically cooperate to deform a surgical fastener 260 to complete ananastomosis between two vessels, e.g., an saphenous vein 320 and anaorta 310 (FIG. 21B).

[0086] The particular surgical instrument 10 shown in the variousfigures is preferably designed to deform an array of surgical fastenerssimilar to fastener 260 shown in FIG. 3 which is generally L-shaped andincludes a base leg 264 and an upwardly extending support leg 262.Preferably, base leg 264 includes a distal end 269 which is sufficientlyshaped to penetrate the saphenous vein 320 and aorta 310 upondeformation of the surgical fastener 260. The upwardly extending supportleg 262 is attached to base leg 264 at a pivot point 265 and includes aninwardly extending prong 267 disposed at its free end designed topenetrate the aorta 310 and secure surgical fastener 260 in positionafter anastomosis. It is envisioned that pivot point 265 may also bedimensioned to include a relief or coined section 261 which mayfacilitate formation of the surgical fastener 260 which will beexplained in more detail below with respect to the operation of thesurgical instrument 10 (See FIGS. 7N and 7S).

[0087] Turning back in detail to FIG. 3, a convexity 263 projectsinwardly between the base leg 264 and the support leg 262 and ispreferably sufficiently dimensioned to cooperate with the base leg 264to retain the saphenous vein 320 against aorta 310 in fluidcommunication after anastomosis as will be explained in greater detailbelow with respect to FIGS. 21B and 24. It is envisioned that thesurgical fastener 260 can be arranged on the SULU in differentpatterns/arrays depending upon a particular purpose.

[0088] As best seen in FIGS. 1, 4, 10 and 11, actuator assembly 20includes a proximal end 24, a distal end 22 and a housing 26 definedtherebetween for storing the internal working components of the actuatorassembly 20. Preferably, a plate 90 covers the internal components ofthe actuator assembly 20 when assembled. More particularly, housing 26includes at least one mechanical interface 23 a which reciprocates witha corresponding mechanical interface 23 b (FIG. 10) disposed on coverplate 90 to matingly engage the two components 26 and 90.

[0089] Actuator assembly 20 also includes a handle 12 which initiatesfiring of the surgical instrument 10 and a spring-loaded thumb tab 30for loading the SULU 100 onto the actuator assembly 20 both of whichwill be explained in greater detail below. Preferably, handle 12 isprovided with an ergonomic surface which is contoured and configured tobe comfortably gripped by the hand of the user during operation of theinstrument.

[0090] Turning now to FIG. 11 which illustrates in detail the internalworking components of the actuating assembly 20 which are preferablyassembled and stored within housing 26. More particularly, the actuatingassembly 20 includes a torsion spring 70 which mounts about post 21which protrudes from housing 26. Spring 70 includes a lower arm 74 whichis biased against a lower portion of the housing and an upper arm 72which is biased against a rotating two-stage cam 60.

[0091] Handle 12 includes a bushing 19 which protrudes laterally fromthe proximal end of the handle 12 and pivotally engages a correspondingrecess 29 disposed within the proximal end 24 of housing 26 to allowpivotal movement of the handle 12 with respect to housing 26. Handle 12also includes a vertically extending slot 27 disposed at its proximalend 24 which receives the proximal end of a lever 16 which moves inconjunction with the handle 12. A pair of flanges 14 a and 14 bdownwardly extend from the handle 12 and receive lever 16 therebetween.A mechanical interface 11 a disposed on handle 12 engages acorresponding mechanical interface 11 b disposed on lever 16 to securethe lever 16 to the handle 12. Preferably, lever 16 has a first recess17 shaped to engage and control the movement of the cam 60 duringdownward movement of the handle 12, the purpose of which will beexplained in more detail with respect to FIG. 21A. Lever 16 alsoincludes a second recess 15 which helps to limit lateral movement of thespring 70 within housing 26.

[0092] As mentioned above, actuating assembly 20 also includes aspring-loaded thumb tab 30 which rests atop housing 26 within alongitudinally extending slot 28 disposed near the distal end 22thereof. As best seen in FIG. 10, slot 28 is formed by notches 18 a and18 b of the housing 26 and cover plate 90, respectively. Tab 30 includesa thumb guide 35 which cooperates with a sliding sleeve 32 to facilitateproximal movement of the tab 30 for loading the SULU. A downwardlydepending flange 34 disposed on tab 30 engages a corresponding slot 33located in a mount 31 disposed atop the sliding sleeve 32. Preferably,sliding sleeve 32 includes a post 36 which is dimensioned to receive atension spring 38 thereon. Spring 38 is biased between a block 47disposed within housing 26 and a proximal edge 37 of sliding sleeve 32such that spring 38 biases sliding sleeve 32 to a distal-most positionproximate distal end 22. Preferably, a distal end 39 of sleeve 32 isarcuate or semi-circular and is dimensioned to slidingly engage acorresponding end 82 of a first retractor 80 to lock the SULU 100 withinthe actuator assembly 20 after the SULU 100 is loaded as will bediscussed in more detail below.

[0093] Actuator assembly 20 also includes first retractor 80 and asecond retractor 50 which each move by way of movement of the handle 12which, in turn, imparts movement to the two-stage cam 60. Firstretractor 80 includes distal and proximal ends 82 and 84, respectively,and is generally tubular in dimension with the exception of an elongatedfurrow 83 extending proximally from distal end 82 for slidinglysupporting sleeve 32. Retractor 80 also includes a slot 85 for receivinga pin 54 for affixing the retractor 80 to the cam 60 and another pair ofslots 87 and 89 located near the proximal end 84 for receiving two camfollowers 51 a and 51 b, respectively. Preferably, the proximal end 84is bifurcated to facilitate insertion of the second retractor 50therein.

[0094] As best seen in FIGS. 11 and 16, a guide 81 engages an elongatedrib 25 a in housing 26 and an elongated rib 25 b in cover plate 90 toslidingly mount the retractor 80 to housing 26. Guide 81 is dimensionedslightly longer than rib 25 a to permit proximal movement of the firstretractor 80 relative to the housing 26 upon activation of the handle12. Preferably, a protective tube 95 is telescopically disposed aboutthe first retractor 80 and moves in conjunction with the sliding sleeve32 by way of slot 96 which secures mount 31 of the sliding sleeve 32therein. It is anticipated that protective tube 95 also helps torestrict lateral movement of the first retractor 80 during retraction.Tube 95 also includes an elongated channel 97 which generally alignswith guide 81 located in the first retractor 80 to mount both componentsto ribs 25 a and 25 b.

[0095] It is contemplated that proximal movement of tab 30 will impartreciprocating proximal movement to the sliding sleeve 32 to exposecarriages 86 and 88 disposed within the first retractor 80 which aredesigned to receive a pair of first and second retracting sleeves 110and 120 (FIGS. 7-9) of the SULU 100. More particularly, and as best seenin FIG. 5, carriage 86 is generally circular in shape and is designed toreceive an outer lip 122 formed by the union of end 122 a and 122 b ofsecond retracting sleeve 120 of the SULU 100. Preferably, carriage 86 isdimensioned larger that the lip 122 so as to permit proximal movement ofthe second retracting sleeve 120 relative to the first retracting sleeve110 as will be explained in more detail with respect to FIG. 22A.Carriage 88 is likewise circular in shape and receives outer lip 112 ofthe first retracting sleeve 110.

[0096] Actuator assembly 20 also includes a handle lock 40 which restsatop the first retractor 80 and extends laterally between the housing 26and the cover plate 90. More particularly, handle lock 40 is mountedwithin slots 93 a and 93 b as best seen in FIG. 10. Handle lock 40includes a post 43 which receives a spring 45 for biasing handle lock 40against a ledge 49 of the housing 26 (FIG. 12). Handle lock 40 alsoincludes a pair of flanges 42 a and 42 b which align with flanges 14 aand 14 b disposed on handle 12. As shown best in FIGS. 21 and 22,downward movement of the handle 12 forces the handle lock 40 initiallydistally against spring 45 until flanges 14 a and 14 b clear flanges 42a and 42 b at which point spring 45 forces handle lock 40 proximally tolock flanges 42 a and 42 b atop flanges 14 a and 14 b and to lock handle12 in a downwardly disposed position. Preferably, flanges 42 a and 42 bdefine a slot 41 for receiving lever 16 therebetween.

[0097] Actuator assembly 20 also includes a second retractor 50 whichincludes an elongated arm 52 having a key-like distal end 53 and aT-shaped heel section 56. Preferably, T-shaped heel section 56 attachesto a tension spring 55 disposed proximally thereof. Second retractor 50is preferably bifurcated at its proximal end forming two longitudinallyextending fins 58 a and 58 b each having a slot 57 and aperture 59 forreceiving cam followers 51 and 51 b, respectively. It is contemplatedthat spring 55 is biased against an elongated stop 65 which rests atoparm 52 and biases heel section 56 proximally when the second retractor50 is retracted which will be explained in more detail below withrespect to the operation of the surgical instrument 10.

[0098] As mentioned above, the first retractor 80 is affixed totwo-stage cam 60 by pin 54. More particularly, cam 60 includes anaperture 61 located near the distal end thereof for receiving pin 54which affixes the cam 60 to the first retractor 80. Cam 60 also includesa pair of generally vertical arcuately-shaped slots 62 and 64 which eachinclude two discrete stages, namely 62 a, 62 b and 64 a, 64 b,respectively, for imparting movement to corresponding followers 51 a and51 b. A nub 66 is located near the uppermost portion of the cam 60 andis dimensioned to slideably engage recess 17 located in lever 16 as bestillustrated in FIG. 12.

[0099] It is contemplated that during downward movement of handle 12,lever 16 will bias nub 66 downwardly such that nub 66 rides proximallyalong recess 17 and causes cam 60 to pivot downwardly about pin 54 asshown best in FIGS. 21A and 22. In turn, followers 51 a and 51 b willride along slots 64 and 62 and cause the first and second retractors 80and 50 to move in a proximal direction which will be explained in moredetail below. Preferably, recess 17, nub 66 and slots 64 and 62 can bedimensioned to control the movement and timing of the cam followers 51 aand 51 b. For example, it is envisioned that the stages 64 a, 64 b and62 a and 62 b can be dimensioned to control the timing and movement ofthe first and second retractors which, in turn, can effect theefficiency of the anastomosis.

[0100] Elongated stop 65 is preferably affixed to the distal end of cam60 and rests atop the second retractor 50. Elongated stop 65 includes adistal end 69 and a proximal end 67 which includes two extendingportions 67 a and 67 b each having an aperture 63 a and 63 b,respectively, disposed therethrough. Preferably, end 69 of stop 65 issufficiently dimensioned such that it engages a corresponding biasingpost 102 located within the SULU 100.

[0101] Preferably, the second retractor 50, the cam 60 and the elongatedstop 65 are pre-assembled prior to insertion into the first retractor80. More particularly and as best illustrated in FIGS. 10-12, elongatedstop 65 is positioned atop arm 52 of the second retractor 50 betweenT-shaped heel section 56 and end 53. Apertures 63 a and 63 b of stop 65align with aperture 61 of cam 60 such that once the cam 60 and theelongated stop 65 are inserted within slot 91 of the first retractor 80,pin 54 locks the two components 65 and 60 together through slot 85.

[0102] Cam 60 is positioned between the extending fins 58 a and 58 b ofthe second retractor 50 such that, when the retractor 50 and cam 60 areinserted within slot 91 of the first retractor, followers 51 a and 51 bare inserted through slot 87 and slot 89, respectively, and slideablycouple the two components 50 and 60 within the first retractor 80.Handle lock 40 is then positioned atop the first retractor 80 asdescribed above. First retractor 80 is then mounted on ribs 25 a and 25b of housing 26 and cover plate 90, respectively and tab 30 along withsliding sleeve 32 are engaged thereon. Handle 12 and lever 16 are thenassembled as described above and pivotably mounted about post 21. Spring70 is then positioned accordingly so as to bias handle 12 againsthousing 26.

[0103] Turning now to FIGS. 7-9 which show an exploded view of theinternal working components of the SULU 100 which as mentioned aboveincludes first retracting sleeve 110 and second retracting sleeve 120which cooperate to deform fasteners 260 and securely fasten thesaphenous vein 320 to the aorta 310 in fluid communication as shown inFIG. 24.

[0104] More particularly and as best seen in FIGS. 7-7D, firstretracting sleeve 110 includes a tube-like base 110 a and an arcuatesleeve cap 110 b which together define the first retracting sleeve 110.Base 110 a includes a circular lip 112 located at its proximal end and asemi-circular anvil 118 a located at the opposite end. A locking tab 116a having an elongated slit 182 a located therein is disposed between lip112 and anvil 118 a. A longitudinally-extending slot 114 a is disposedbetween the lip 112 and the locking tab 116 a. At least one interface117 a downwardly depends from base 110 a to mechanically engage acorresponding mechanical interface 117 b disposed on sleeve cap 110 b(FIG. 7). A flange 113 a is preferably disposed beneath slot 114 a andis sufficiently dimensioned to engage corresponding flanges 113 b ₁ and113 b ₂ located on sleeve cap 110 b. Slot 114 a is sufficientlydimensioned to receive a tab 138 a (FIG. 13) which projects from anupper surgical fastener support 130 a which is explained in more detailbelow.

[0105] Sleeve cap 110 b includes a semi-circular anvil 118 b and abifurcated proximal end 113 composed of flanges 113 b ₁ and 113 b ₂which together define a slot 114 b for receiving a tab 138 b whichprojects from a lower surgical fastener support 130 b which is explainedin more detail below. Sleeve cap 110 b also includes mechanicalinterfaces 117 b which couples with corresponding mechanical interfaces117 a disposed on base 110 a to engage sleeve cap 110 b with base 110 a.A locking tab 116 b having an elongated slit 182 b located therein isdisposed between proximal end 113 and anvil 118 b. Alongitudinally-extending opening 111 b is preferably disposed proximatelocking tab 116 b and aligns with a corresponding opening 111 a in base110 a (FIG. 7C) such that the saphenous vein 320 can be receivedtherethrough as seen best in FIGS. 17 and 18.

[0106]FIGS. 2A and 7D show a greatly enlarged view of anvil 118 a whichincludes a semi-annular array of fastener support channels or cradles119 a each configured and dimensioned to support a surgical fastener 260therein. Sleeve cap 110 b also includes fastener support channels 119 bwhich, when base 110 a and sleeve cap 110 b are assembled, align to forma circular array about the internal surfaces of anvil 118 a and 118 b.It is envisioned that anvils 118 a and 118 b can be designed to supportdifferent arrays of surgical fasteners 260 depending upon a particularpurpose. Each channel 119 a and 119 b is preferably separated by ananchor 187 a and 187 b (FIG. 7) which releasably retains a projectingfinger 124 a, 124 b of second retracting sleeve 120 (FIG. 2A).

[0107] Support channels 119 a and 119 b each include proximal ends 186 aand 186 b and distal ends 184 a and 184 b which are radially offset fromone another to seat surgical fastener 260 within channels 119 a and 119b in a radially offset manner the purpose of which will be explainedbelow with respect to the operation of the surgical instrument 10. Thedistal end 184 a of each channel 119 a is preferably arched so as tocorrespond to the arcuate shape of the end of the surgical fastener 260as best seen in FIG. 13A. It is anticipated that arching the distal end184 a will cause the surgical fastener 260 to deform upwardly andproximally upon retraction of the first retracting sleeve 110 by thefirst retractor 80 as explained below with reference to FIGS. 21-22.

[0108] FIGS. 7-7D also show second retracting sleeve 120 which includesan upper cuff 120 a, a lower cuff 120 b and an outer cap 128 whichtogether define the second retracting sleeve 120. More particularly,upper cuff 120 a includes a semi-annular lip 122 a at one end and aplurality of retention fingers 124 a at the opposite end. Upper cuff 120a also includes a first slot 101 which preferably aligns with slot 114 aof the first retracting sleeve 110 a to receive tab 138 a of upperfastener support 130 b therethrough (FIG. 20). A second slot 126 areceives locking tab 116 a when cuff 120 a is slideably mounted atopbase 110 a. Interfaces 129 a mechanically engage correspondinginterfaces 129 b located on lower cuff 120 b.

[0109] Lower cuff 120 b includes a bifurcated proximal end 107 whichcomprises flanges 107 b ₁ and 107 b ₂ which define a slot 108 forreceiving tab 138 b of lower fastener support 130 b therethrough and aplurality of retention fingers 124 b which extend from the opposite endthereof. A slot 126 b is disposed between the flanges 107 b ₁, 107 b ₂and the fingers 124 b for receiving locking tab 116 b of the sleeve cap110 b when cuff 120 b is slideably mounted thereon. Alongitudinally-extending opening 121 b is disposed proximate slot 126 band aligns with a corresponding opening 121 a in upper cuff 120 a andalso aligns with openings 111 a and 111 b of the first retracting sleeve110 such that the saphenous vein 320 can be received therethrough asseen best in FIGS. 17 and 18.

[0110] A semi-circular cuff cap 128 is disposed atop lower cuff 120 band mechanically interfaces with upper cuff 120 a such thatsemi-circular lips 122 a and 122 b for circular lip 122. Moreparticularly, cuff cap 128 includes a plurality of detents 123 b whichmechanically engage a corresponding plurality of notches 123 a locatedin upper cuff 120 a such that the cuff cap 128, upper cuff 120 a andlower cuff 120 b all move in unison upon retraction of the secondretracting sleeve 120. Sleeve cap 128 is preferably bifurcated at itsdistal end forming slot 109 which is dimensioned to receive tab 138 b.

[0111] As can be appreciated, fingers 124 a and 124 b move uponretraction of the second retracting sleeve 120 to release the surgicalfasteners 260 after firing. More particularly and as best seen in FIGS.2A and 7A, the distal end of each finger 124 a is forked and includes afirst prong 127 a which retains a surgical fastener 260 within thefastener support channels 119 a and a second prong 125 a whichinterlocks with anchor 187 a to releasably lock the finger 124 a to thefirst retracting sleeve 110 until released by the second retractor 50(FIGS. 22A and 22B) which will be explained in more detail with respectto the operation of the surgical instrument 10. Likewise, each finger124 b of lower cuff 120 b includes prongs 127 b and 125 b which operatesin the same manner.

[0112] As mentioned previously, the SULU 100 also includes fastenersupport 130 which has an upper support 130 a and a lower support 130 bwhich, when assembled, internally house the first and second retractingsleeves 110 and 120, respectively, along with their individual workingcomponents. Upper support 130 a and lower support 130 b each include adistal end 135 a and 135 b each having an array of braces 137 a and 137b, respectively, which project radially from distal ends 135 a and 135b. As best illustrated in FIG. 2, each brace 137 a and 137 b supports anupwardly extending support leg 262 of a surgical fastener 260 disposedwithin one of the channels 119 a or 119 b. A plurality of radiallyextending slots 139 a and 139 b are disposed between each support brace137 a, 137 b for retaining a surgical fastener 260 therein and forrestricting unwanted lateral movement of each fastener 260. It isanticipated that each surgical fastener 260 is positioned within a slot139 a, 139 b such that convexity 263 projects outwardly from brace 137a, 137 b and, after anastomosis, cooperates with the base leg 264 toretain the saphenous vein 320 against LAD and/or aorta 310 (FIGS. 21Band 24).

[0113] Upper support and lower support 130 a and 130 b, respectively,also include hinges 136 a and 136 b which, when the SULU 100 isassembled, matingly engage one another to allow pivotable movementbetween the supports 130 a and 130 b from an open position (FIG. 23) toa closed position (FIG. 2). Preferably, a pin 180 secures the two hinges136 a and 136 b together (FIG. 6). Upper and lower supports 130 a and130 b each include a longitudinally-extending opening 133 a (FIG. 23)and 133 b which aligns with openings 121 a, 121 b, 111 a and 111 bdescribed above to receive saphenous vein 320 therethrough as seen bestin FIGS. 17 and 18. Longitudinally oriented slots 131 a and 131 b aredisposed adjacent openings 133 a and 133 b on the upper and lowersupport members 130 a and 130 b, respectively, for receiving lockingtabs 116 a and 116 b in much the same manner as described above withrespect to slots 126 a and 126 b of the second retracting sleeve 120.

[0114] Lower support 130 b includes a pair of shoulders 132 a and 132 bdisposed on opposite sides of opening 133 b for slideably receiving acorresponding pair of flanges 144 a and 144 b associated with an upperlocking sleeve 140 a. More particularly, each flange 144 a and 144 bextends distally from the upper locking sleeve 140 a to define a notch149 a and 149 b, respectively, therein for receiving shoulders 132 a and132 b of lower support 130 b.

[0115] Upper locking sleeve 140 a includes a C-shaped clip 146 a (FIG.8) disposed therein which has pair of opposing hooks 147 a forsnap-lockingly engaging slit 182 a of locking tab 116 a of firstretracting sleeve 110. A lower locking sleeve 140 b operates in asimilar manner and includes a pair of opposing hooks 147 b forsnap-lockingly engaging slit 182 b of locking tab 116 b of firstretracting sleeve 110. Upper locking sleeve 140 a also includes anopening 141 a which aligns with openings 133 a, 133 b, 121 a, 121 b, 111a and 111 b described above to receive saphenous vein 320 therethroughas seen best in FIGS. 17 and 18. It is envisioned that upon retractionof the second retracting sleeve 120, upper locking sleeve 140 a willmove proximally relative to shoulders 132 b and 134 b and disengageshoulders 132 a, 132 b which, in turn, will allow the upper and lowersupports 130 a and 130 b to pivot about pin 180 and release thesaphenous vein 320 (FIGS. 21E and 23). This will be explained in greaterdetail with respect to the operation of the instrument as describedbelow.

[0116] SULU 100 also includes a biasing post 102 which mechanicallyaligns upper and lower supports 130 a and 130 b in fixed relationrelative to one another. More particularly, biasing post 102 includes aproximal end 103 and a distal end 105 and has a vertically orientedcavity 106 disposed therethrough for receiving tabs 138 a and 138 b ofthe upper and lower supports 130 a and 130 b, respectively. As mentionedabove, tabs 138 a and 138 b pass through slots 114 a, 114 b of the firstretracting sleeve 110 and through slots 101, 108 and 109 of the secondretracting sleeve 120 and mechanically align with one another withincavity 106 as best seen in FIG. 21B.

[0117] Biasing post 102 also includes a tapered spacer 104 disposedalong the outer periphery thereof for frictionally locking the firstretracting sleeve 110 in a retracted position after the first retractingsleeve 110 is withdrawn by the first retractor 80. More particularly,when the SULU 100 is assembled and prior to firing the surgicalinstrument 10, biasing post 102 is disposed relative to the firstretracting sleeve 110 such that spacer 104 is proximal to lip 112 (FIG.13). During retraction of the first retracting sleeve 110, lip 112 isforced over spacer 104 and the first retracting sleeve 110 is lockedinto retracted position and prevented from recoiling. As explained ingreater detail below, locking the first retracting sleeve 110 in aretracted position also pre-disposes the second retracting sleeve 120for retraction relative to the first retracting sleeve (FIG. 22A).

[0118] FIGS. 7E-7I show one embodiment of a retaining ring or strap 500which is designed for use in connection with the SULU 100. It isenvisioned that the retaining ring 500 will maintain a consistentanastomosis between the two luminal vessels 310 and 320 after the SULU100 is fired and the surgical fasteners 260 are released.

[0119] More particularly and as best shown in FIG. 7E, the retainingring 500 is preferably constructed from a thin sheet-like, semi-pliablematerial which is biologically compatible with the various luminalvessels. Retaining ring 500 is generally circular in shape but may bedimensioned in other shapes depending upon the particular configurationof the surgical fasteners 260 when positioned in the SULU 100, e.g.,ovoid. Retaining ring 500 includes a series of alternating loops 510 andarcuate portions 520 which are formed radially about an axis “A”extending through ring 500. Each loop 510 defines an aperture 512therein which is dimensioned to receive the distal end 269 of a surgicalfastener 260.

[0120] It is envisioned that the overall width “W” of the retaining ring500 is dependent upon both the radial dimensions of a major diameter “D”of the loops 510 and the distance “E” which the arcuate portions 520extend beyond the diameter of the loops 510. It is envisioned thateither of these dimensions “D” and/or “E” may be varied to alter theoverall width “W” of the ring 500 depending upon a specific purpose.

[0121] As best shown in FIG. 7F, retaining ring 500 is positioned overthe anvils 118 a, 118 b of SULU 100 such that the distal end 269 of eachsurgical fastener 260 is positioned through a respective aperture 512 ofloop 510 and an arcuate portion 520 is positioned between each surgicalfastener 260. It is envisioned that the ring 500 is held in lightfriction fit or tensile engagement with the surgical fasteners 260 toprevent inadvertent slippage prior to firing of the SULU 100.

[0122]FIGS. 7G and 7H show the position of the ring and the surgicalfasteners after firing the SULU 100. As can be appreciated and asexplained in more detail below (i.e., with respect to loading theinstrument 10, the everting of vein 320 over the anvils 118 a, 118 b andthe firing of the instrument 10), when fired, the distal ends 269 of thesurgical fasteners 260 are forced rearward towards the proximal end ofthe SULU 100. Simultaneously during deformation, the distal ends 269 areforced through the apertures 512 such that the distal ends 269 piercevein 320 thereby securing the vein 320 between the ring 500 and thedistal end 269 of the surgical fastener 260 (See FIG. 7H). It isenvisioned that the pivot point 265 may also be dimensioned to include arelief or coined section 261 which may facilitate formation of thesurgical fastener 260 (See FIGS. 7N and 7S).

[0123] As can be appreciated, the ring 500 prevents the vein 320 fromslipping along the base leg 264 of the fastener 260. More particularlyand as best seen in FIG. 7H, the arcuate portions 520 which, asmentioned above, extend beyond the loops 510, abut the outer surface ofthe vein 320 and prevent the ring 500 from moving along base leg 264 offastener 260. The inner periphery of the aperture 512 may also be coatedwith a friction-like material which also limits slippage of the rings500 against the base leg 264 which, as a result, also prevents the vein320 from sliding. As best illustrated in FIGS. 7N-7S, it is alsoenvisioned that fastener 260 may be manufactured to include aprotuberance 268 which extends beyond the outer surface of base leg 264.Preferably, protuberance 268 is dimensioned to engage and/or abutagainst the ring 500 to prevent the ring 500 from sliding along the baseleg 264 of fastener 260. Alternatively, the fastener 260 may bedimensioned to include a coined surface (not shown) along base leg 264which will also prevent the ring 500 from sliding.

[0124] As can be appreciated, preventing the slippage of the vein 320along fastener 260 will maintain a reliable and consistent anastomosisbetween the luminal vessels 310 and 320 as best shown by the internalview of FIG. 71.

[0125]FIGS. 7J and 7K show an alternate embodiment of a retainer ring600 in accordance with the present disclosure. More particularly,retaining ring 600 includes many of the features of retaining ring 500,i.e., alternating loops 610 and arcuate portions 620 and apertures 612associated with each loop 610, with the exception that ring 600 includesa slit 614 disposed along the inner periphery of aperture 612. It isenvisioned that slit 614 will permit the ring 600 to wedge against thebase leg 264 of surgical fastener 260 after firing of the SULU 100. Ascan be appreciated, this will also prevent the vein 320 from sliding.

[0126]FIGS. 7L and 7M show other alternate embodiments of retainingrings. More particularly, FIG. 7L shows an alternate embodiment of aretaining ring 650 which includes arcuate portions which straightenafter the SULU 100 is fired. It is envisioned that straightening thering 650 expands the overall radial dimensions of the ring 650 and, assuch, holds the loops 660 in friction-fit engagement against the baseleg 264 of the surgical fasteners 260 after the SULU 100 is fired. FIG.7M shows another embodiment of the retaining ring 680 fabricated from athin wire-like material.

[0127] Turning now in detail to the loading of the SULU 100 withinactuator assembly 20 as best seen in FIG. 5, thumb tab 30 is movedproximally by way of thumb guide 35 against spring 38 which, in turn,moves sleeve 32 and protective cover 95 proximally to expose carriages86 and 88. The SULU 100 is then loaded within actuator assembly 20 byplacing lip 112 within carriage 88 and lip 122 within carriage 86. Asbest shown in FIG. 13, lip 122 is positioned near the distal end ofcarriage 86 which allows lip 122 and, hence, second retracting sleeve120, to move independently from the first retracting sleeve uponactivation of the second retractor 50. In contrast, carriage 88 isdimensioned smaller than carriage 86 such that lip 112 fits snuglywithin carriage 88. Once the SULU is positioned within carriages 86 and88, thumb tab 30 is released and spring 38 biases sleeve 32 andprotective cover 95 distally over lips 112 and 122 to lock the SULU 100within the actuator assembly 20.

[0128] In use and as shown in FIGS. 17-24, surgical instrument 10facilitates the performance of a vascular anastomosis and eithereliminates and/or minimizes the need for manual suturing of the vessels.The method and usage described herein will be addressed in terms ofvascular anastomosis performed on a beating heart. However, thepresently disclosed surgical instrument 10 may also be used inperforming anastomoses of other tubular or luminal body structureswithout departing from the scope of the present disclosure. For example,surgical instrument 10 may be used in conventional open CABG proceduresusing a median sternotomy or other large incision without stopping theheart. Alternatively, the thoracic “window” procedure may be used toachieve access to the heart. The “window” approach involves a smallerincision and less displacement of the ribs, and therefore is lesstraumatic to the patient. For this approach, conventional surgicaltechniques are used to determine the location of the incision to accessthe chest cavity.

[0129] To gain access to the heart, after an incision is made, asurgical retractor assembly may be used to separate the ribs at the siteof the incision as shown in FIG. 25. Specifically, a base 410 is placedon the chest of the patient with the central opening defined by the basebeing positioned over the operative site. Retractor assemblies 430 aremounted to the base 410 at various locations. Each retractor assembly430 includes a blade having a hook to engage either a rib or the sternumtherewith. The retractor assemblies are mounted and used to retract ribsuntil a sufficiently large opening in the chest cavity is defined toprovide direct access to the heart. For example, the sternum and thefourth and fifth ribs can be split apart to create a window. Otherconfigurations of spreading the ribs and/or selectively cuttingindividual ribs away from the sternum may also be utilized for aparticular procedure.

[0130] Once the desired access to the heart is achieved, the graftvessel, e.g., the saphenous vein 320 is dissected and harvested from theleg, and a free end of the vessel is exposed. The occluded coronaryartery, e.g., the LAD 310, is then prepared for receiving the saphenousvein 320 graft. The heart is positioned in the desired orientationeither by traction sutures passing through the pericardium or bymanipulation with heart manipulation instruments which are held by thesurgical personnel or clamped in a fixed orientation to a base such asthe retractor assembly base. Blood flow through the aorta 310 can berestricted by cardiopulmonary bypass and pericardial cooling.Alternatively, a dampening instrument may be applied directly on theaorta 310 to restrict blood flow and reduce movement of the h art nearthe aorta 310.

[0131] Alternatively, the present disclosure also provides for a novelmethod for creating the vascular anastomosis without restricting theblood flow through the luminal structure 310 via a dampening instrument,e.g., cross clamp or partial occluding clamp, as described above. Moreparticularly, two particular clamping techniques are widely known andused. One clamping technique involves fully cross clamping the luminalstructure 310 while the heart is stopped to sew the distal anastomosis.The heart is then restarted and the proximal anastomosis is sewnutilizing a partial occluding clamp. This technique is described in TheManual of Cardiac Surgery Second Edition by Harlan, Starr and Harwin anddescribes in particular left-sided graft. The other technique involvesfully cross clamping the aorta while sewing the proximal and distalanastomosis.

[0132] Other commonly known techniques involve performing coronaryartery bypass grafting without the use of cardiopulmonary bypass. Moreparticularly, this technique involves utilizing either a mechanicaland/or vacuum-assisted instruments for distal or proximal anastomosisstabilization, e.g., the Precision-Op™ instrument jointly owned byUnited States Surgical a division of the Tyco HealthCare Group andHeartport, Inc. These techniques are also described in The Manual ofCardiac Surgery Second Edition.

[0133] In contrast, the present disclosure also relates to a novelmethod for creating a vascular anastomosis without the utilization ofany of the aforementioned dampening instruments. The method is shown inthe schematic illustrations of FIGS. 27-30. More particularly, thepresent disclosure relates to a method for creating a vascularanastomosis including the steps of:

[0134] creating an aortotomy in the first luminal structure, e.g., aorta310;

[0135] covering the aortotomy to stop blood flow through the aortotomy;

[0136] inserting an anastomotic device having a second luminalstructure, e.g., vein 320, associated therewith into the aortotomy; and

[0137] actuating the anastomotic device to create an anastomosis betweenthe first and second luminal structures.

[0138] It is envisioned that the user's finger, a surgical instrumentor, perhaps, another object may be employed to cover the aortotomy tostop the blood flow. Moreover, the anastomosis can be formed utilizingone of the embodiments described and/or referenced herein. The aortotomymay be made in the first luminal structure 310 with a scalpel, trocar,punching device and/or any other instrument known in the art. Forexample, one such device known as an aortic punch may be employed foruse in creating the aortotomy and is shown in FIGS. 31-32B.

[0139] Aortic punch 800 includes left and right housings 810 a and 810b, respectively, which, when mechanically engaged form a complete cavity813 for housing the internal working components of the aortic punch 800which are described in further detail below. It is envisioned that thetwo housings 810 a and 810 b are engaged by way of mechanical interfaces840 which are positioned at various locations along each housing 810 a,810 b. For example, housing 810 a may include a first mechanicalinterface, e.g., a slot 840 a, which engages a corresponding detent ortab 840 b on housing 810 b. It is envisioned that numerous mechanicalinterfaces may be employed to join the two housing halves 810 a, 810 beither permanently for use with a disposable unit or selectively for usewith a reusable instrument. Once assembled, the two proximal ends of thehousings 810 a, 810 b form a mutual flange 814 which biases each plunger812, 822 during activation thereof.

[0140] As best illustrated in FIG. 31 which depicts the assembledinstrument, aortic punch 800 includes two plunger-like actuators, 812and 822, respectively, a cutting assembly 830 and a piercing needle 820.The two plungers 812 and 822, respectively, are independently operableby the user and move the cutting assembly 830 and needle 820 relative toone another to create the aortotomy in an aortic wall, e.g., luminalstructure 310.

[0141] More particularly and as best illustrated in FIGS. 32A and 32B,distal movement of plunger 822 relative to flange 814 a, 814 b by theuser exposes the needle 820 along axis “A” and, when inserted by theuser, will pierce the aortic wall 310. A return spring 845 is preferablyassociated with the plunger 822 such that distal movement of the needle820 along axis “A” relative to flange 814 biases the spring 845 againstflange 814. The plunger 822 also includes an elongated sleeve 841 havinga spline 843 at the distal end and a proximal end (not shown) whichaffixes to the plunger 822. It is envisioned that spline 843 facilitatesrotational movement of the cutting assembly 830 relative to the needle820 during movement of plunger 812 as described below.

[0142] Plunger 822 also includes a flange-like proximal end 827 whichpermits facile activation of the plunger 822 by the user. A cap 848 isaffixed to the sleeve 841 and includes a skirt or shoulder portion 849which biases spring 835 when the plunger 812 is activated as explainedin more detail below with respect to the operation of the punch 800.

[0143] Needle 820 preferably includes a barb 823 which is dimensioned tocatch the side of the aortic wall 310 upon return of spring 845 suchthat the needle 820 remains in tension against the aortic wall 310. Thepurpose of maintaining the barb 823 in tension against the aortic wall310 is described in more detail below with respect to the operation ofthe punch 800. It is envisioned that other mechanisms or methods may beemployed to hold the needle 820 in tension against the aortic wall 310,e.g., vacuum, hydraulic, magnetic, etc.

[0144] As mentioned above, plunger 812 actuates the cutting assembly 830which creates the aortotomy in the aortic wall 310. Plunger 812 includesan elongated body 818 having a distal end 815 which mounts a returnspring 835 and a flange-like proximal end 816 which is dimensioned topermit facile activation of the plunger 812 by the user. As best seen inFIG. 32B, elongated body 818 defines a cavity 817 therein which housesan elongated rack 855 which meshes with a corresponding pinion gearassembly 831 to convert linear movement of the plunger along axis “A” torotational movement of the cutting assembly 830. Cutting assembly 830also includes a circular knife tube 833 having a serrated tip 832 at thedistal end thereof and the gear assembly 831 engaged at the proximal end834 thereof.

[0145] Other configurations of the circular knife 833 are alsocontemplated, e.g., non-serrated tips and/or angled/beveled tips. Thegear assembly 831 includes a pinion gear 842 which is positionedtransversally to axis “A” which has a plurality of teeth 839 (FIG. 32B)on one side thereof which mesh and engage the rack 855 and a beveledgear 847 (FIG. 32A) on the opposite side thereof which meshes andengages gear 836 disposed at the proximal end 834 of the cutting tube833. As can be appreciate, movement of the pinion gear 842 along rack855 rotates gear 836 which causes knife tube 833 to rotate.

[0146] During assembly, the knife tube 833 is fed through plunger body818, through return spring 835, through plunger 822, through cap 848 andatop sleeve 841 such that the serrated tip 832 of the knife tube 833encompasses the spline 843 and needle 820. The proximal end 834 of knifetube 830 and the gear assembly 831 are positioned within cavity 817 suchthat the gear assembly 831 engages rack 855 (See FIG. 32A. A positioningpost 844 may be employed to ensure proper engagement of gear assembly831 the rack 855. The return spring 835 is positioned between shoulder849 of spring cap 848 and the distal end 815 of plunger 812 such thatforward linear movement of plunger 812 will bias spring 835 againstshoulder 849.

[0147] As can be appreciated, linear movement of the plunger 812 alongaxis “A” moves the rack 855 relative to the flange 814 which, in turn,rotates pinion gear 842 and, therefore, cutting assembly 830 in thedirection of arrow “R” about needle 820. As mentioned above this biasesspring 835 against shoulder 849 such that a release of the pressure onplunger 812 will return plunger 812 to its initial, pre-activatedposition. It is contemplated that a release of the pressure on plunger812 may also reverse the rotation of knife tube 830 depending upon aparticular purpose. Alternatively, it is also envisioned that a clutch,neutral gear or other mechanism (not shown) may be employed to limit therotation of knife tube 830 in a single direction depending upon aparticular purpose.

[0148] An aortotomy is created in the luminal structure 310 in thefollowing manner: The instrument is held in the user hand in asyringe-like manner. Plunger 822 is activated, i.e., depressed, whichexposes the barb 823 of needle 820 from the interior of knife tube 830along axis “A”. The user then pierces the tissue 310 with the exposedneedle 820 and barb 823. Plunger 822 is then released and the returnspring 845 provides tension on the barb 823 to retain the needle 820 inthe tissue 310 against serrated tip 832. Plunger 812 is then depressedwhich moves the rack 855 relative to the flange 814 causing gearassembly 831 to rotate in the manner described above. As the userdepresses the plunger 812 distally along axis “A”, the circular knifetube 833 rotates the serrated tip 832 about needle 820 to cut the tissue310.

[0149] Once the tissue is cored from the surrounding tissue 310, thebarb 823 loses tension against the aortic wall 310 and the return spring845 retracts the needle 820 and the tissue core into a cavity 860 in thecircular knife tube 833. The user then releases the plunger 812 toreturn the punch 800 to the pre-activated configuration for re-use. Itis contemplated that the punch 800 can be equipped with a lock-outmechanism (not shown) which prevents the punch 800 from being re-used.

[0150]FIGS. 33 and 34 show another configuration of an aortic punch 910.Aortic punch 910 includes a tubular housing 920 having a centrallongitudinal axis “X” defined therethrough and a plunger assembly 930slidingly engaged therein. Housing 920 has a distal end portion 922 anda proximal end portion 924 defined by a tubular wall 926. Distal endportion 922 includes an area having a first inside circumference atleast slightly smaller than a second inside circumference of proximalportion 924. Distal end portion 922 also includes a recessed portion 921of increased circumference extending from distal end 922 to a firstshoulder 923. Proximal portion 924 includes a second shoulder 925separating the first inside circumference and the second insidecircumference. Tubular wall 926 defines at least one through hole. Afirst through hole 927 is defined in a portion of increased outsidecircumference in distal portion 922 and a second through hole 929 ispositioned in proximal portion 924.

[0151] Housing 920 is preferably fabricated of medical grade plastic,but it can be made from a suitable metal or composite medical gradematerial. Housing 920 may be fabricated as a single component, injectionmolded around other components for example, or it can be made of one ormore parts and assembled into housing 920. Aortic punch 910 can beconfigured for disassembly and sterilization or as a disposable device.

[0152] A circular knife tube 950 includes a cutting distal end 952 witha cutting edge 951 and a proximal end 954 configured for positioning inrecess 921. Proximal end 954 is configured to be positioned adjoiningshoulder 923 and also defines a hole 953 that is positioned foralignment with through hole 927. Hole 927 is configured for thepositioning of a retention mechanism (not shown) such as a cantileveredportion of housing 920, set screw or pin, for example, as mechanicalattachment means to fix knife tube 950 in position in housing 920.Housing 920 and knife tube 950 are configured to rotate about axis “X”independent of or concurrent with plunger assembly 930.

[0153] Plunger assembly 930 includes a plunger 940, a member 970 andbarb 980. Plunger 940 is at least partially positioned in housing 920and includes a distal end portion 942 and a proximal end portion 944.Distal end portion 942 defines a receptacle 941 and has an outsidecircumference configured to be slidingly engaged with the second insidecircumference of proximal portion 924. Plunger 940 also includes aportion of reduced circumference 943 between proximal end 944 and distalend 942. Reduced circumference 943 is configured to be engaged by asimilar retention mechanism (not shown) as that described abovepositioned in through hole 929 and extending beyond the outsidecircumference of plunger distal end 942 into the area adjoining theportion of reduced circumference 943. The length of reducedcircumference 943 in combination with the retention mechanism isconfigured to limit the travel of plunger 940 along axis “X”.

[0154] Plunger assembly 930 is described as having separate elements,but in an alternative embodiment, assembly 930 could be a singlecomponent made of a suitable medical grade plasticor metal. In a furtheralternative embodiment, at least a portion of barb 980 is a medicalgrade metal. A biased member 960 is positioned between distal end 942and second shoulder 925 and is preferably a coiled spring, but it caninclude alternative embodiments such as a plurality of leaf springs orother resilient or flexible elements that act to provide a proximal biasto plunger 940. Bias member 960 in one preferred embodiment is connectedto distal end 942 by a retention mechanism.

[0155] Member 970 includes a distal end portion 972 and a proximal endportion 974 that is configurable as a solid rod or a tubular sleevedepending on the desired application and materials of construction.Member 970 is at least configured to be slidingly engaged with the firstinside circumference of distal end portion 922. Distal end 972 includesa portion of reduced circumference 971. Reduced circumference portion971 performs a similar function as portion of reduced circumference 943.The retention mechanism associated with through hole 927 similarlyextends into the area adjoining reduced portion 971 to limit themovement of member 970 and circular knife 950 along axis “X”. Theretention mechanisms and portions of reduced diameter 943 and 971provide a redundant safety system to preclude an excessive forwarding ofplunger assembly 930.

[0156] Distal end portion 972 also includes a barb 980. Barb 980includes a distal end portion configured as a piercing needle 982 havinga general cone shape tip 981 and a maximum circumference 983. A proximalend portion 984 has a tubular shape with a substantially smallercircumference than maximum circumference 983. In one preferredembodiment, the outside circumference of cone 982 at its widest point issubstantially less than the inside circumference of circular knife tube950. Barb 980 is configured to pierce and retain contact with a portionof tissue when a proximal force in the direction of arrow “A” is placedagainst plunger assembly 930 relative to housing 920. Barb 980 iscoincidental with the central longitudinal axis “X” and acts as a pointof rotation for circular knife tube 950 and housing 920.

[0157] Proximal end portion 974 is configured to be at least partiallypositioned within receptacle 941 and connected by a pin, set screw, orother conventional connecting means. Proximal end portion 974, distalend 942, shoulder 925, and the inside circumference of proximal endportion 924 retain bias member 960 in position in an alternativeembodiment. Aortic punch 910 can be employed to join varying tissueportions or cavities, but is best described in one preferred applicationin conjunction with an aortotomy to create an opening in the aorta forthe suturing of a graft. Barb 980 is aligned with a predetermined centerof the aortotomy. Plunger ass mbly 930 is then pressed distally in thedirection of arrow “B” to forward barb 980 through a portion of aortictissue.

[0158] Once barb 980 has penetrated the tissue portion, plunger assembly930 is released by the surgeon and bias member 960 provides the proximalforce in the direction of arrow “A” to retain the tissue portion incontact with circular knife 950. With the aortic tissue portion beingheld in contact with circular knife 950, plunger assembly 930 is heldapproximately fixed in position while housing 920 and circular knife 950are manually rotated about axis “X” to the cut a circular hole in theaorta. Upon the severing of the aortic tissue portion for the aortotomy,the tissue portion is at retained by barb 960 and the apparatuswithdrawn.

[0159] Turning now in detail to the operation of the surgical instrument10 and in particular, the operation of the SULU 100 as detailed in FIGS.17-24, once the saphenous vein 320 has been harvested, the user insertsthe free end 322 into opening 133 of the SULU and pull via a surgicalhook or graspers the free end 322 towards the distal end of the SULU100. The user then everts the saphenous vein 320 over the anvils 118 a,118 b of the SULU 100 such that the free end 322 of the saphenous vein320 is retained by end 269 of the surgical fasteners 260. Everting ofthe saphenous vein 320 may be achieved by any suitable known instrumentsand/or techniques such as by using graspers.

[0160] The remaining portion of the saphenous vein 320 is preferablypositioned away from the instrument 10 to facilitate insertion of thesaphenous vein 320 into the aorta 310 as shown in FIG. 18. The user theninserts the end of the SULU 100 into an incision 312 in the aorta suchthat the distal end 269 of each of the plurality of fasteners 260 andthe everted end portions 322 of the saphenous vein 320 are sufficientlyinserted into and through incision 312 (FIGS. 19 and 20). As seen bestin the enlarged view of FIG. 20, the support leg 262, convexity 263 andprong 267 of each surgical fastener 260 remains outside incision 312.The instrument is now preset for firing.

[0161] FIGS. 21-22 show the firing sequence of instrument 10, i.e., whenthe handle 12 is depressed by the user. As best shown in FIGS. 21 and21A, as handle 12 is depressed downwardly in the direction of referencearrow “A”, lever 16 simultaneously imparts movement to both handle lock40 and cam 60. More particularly, downward movement of handle 12 causesflanges 14 a and 14 b of lever 16 to urge flanges 42 a and 42 b ofhandle lock 40 distally against spring 45 in the direction of referencearrow “B” (FIG. 21). At the same time, handle 12 causes recess 17 oflever 16 to bias nub 66 which, in turn, causes cam 60 to deflectdownwardly and proximally as best seen in FIG. 21A. Preferably, recess17 in lever 16 is dimensioned to control the specific movement of nub 66within recess 17 which, in turn, controls the overall movement of cam60. Downward and proximal movement of cam 60 causes cam followers 51 aand 51 b to move within the first cam stages 64 a and 62 a of slots 64and 62, respectively, which, in turn, moves the first retractor 80 andprotective cover 95 proximally in the direction of reference arrow B.

[0162] As seen best in FIG. 21, as retractor 80 moves proximally as aresult of the movement of cam followers 51 a and 51 b within slots 64and 62, slot 85 moves proximally until it abuts pin 54. Preferably, whenslot 85 abuts pin 54, cam 60 is forced more downwardly about pin 54 suchthat cam followers 51 a and 51 b move more proximally to engage thesecond stages 64 b and 62 b of the cam slots 64 and 62, respectively.

[0163] As mentioned above, the first retractor 80 retracts the firstretracting sleeve 110 (FIG. 21) which, in turn, causes surgicalfasteners 260 to deform as shown in FIGS. 21B and 21D. More particularlyand as best shown in FIG. 21B, proximal movement of the first retractor80 causes both the first retracting sleeve 110 and the second retractingsleeve 120 to move proximally relative to biasing post 102 until biasingpost 102 abuts the end 69 of elongated stop 65. As a result, anvils 118a and 118 b deform the distal ends 269 of surgical fasteners 260upwardly and proximally towards braces 137 a and 137 b, respectively,i.e., arc-like distal ends 184 a and 184 b cause surgical fasteners 260to deform upwardly and proximally upon retraction of the firstretracting sleeve 110. At the same time, the aorta 310 is forcedslightly proximally and extending prongs 267 penetrate to hold the aorta310 in position as best seen in FIG. 22A.

[0164] It is anticipated that the radially offset orientation of theopposite ends 186 a, 186 b and 184 a, 184 b of the support channels 119a and 119 b, respectively will cause the opposite ends 267 and 269 ofthe surgical fasteners 260 to deform at an angle α relative to oneanother as best shown in FIG. 21D. This allows end 269 to deformproximal to braces 137 a and 137 b. Preferably, braces 137 a and 137 bhave a tapered cross section to deform end 269 of surgical fastener 260radially from end 267 during deformation.

[0165]FIG. 21C shows the resulting position of the spacer 104 of thebiasing post 102 after the first retractor 80 retracts the first andsecond retracting sleeves 110 and 120, respectively. More particularly,spacer 104 frictionally locks the first retracting sleeve 110 relativeto the second retracting sleeve 120 and prevents the first retractingsleeve 110 from recoiling after firing.

[0166]FIG. 21E shows the proximal movement of the locking sleeve 140 aas a result of the movement of the first retracting sleeve 110. Moreparticularly, when the first retracting sleeve 110 is retractedproximally, locking tab 116 a retracts within slot 131 a of support 130a and biases locking sleeve 140 a in a proximal direction as well asseen by reference arrow “C”. Proximal movement of the locking sleeve 140a relative to support 130 a disengages flanges 142 a and 144 a fromshoulders 132 b and 134 b, respectively, of support 130 b which, inturn, unlocks supports 130 a and 130 b from one another thus permittingpivotal mov ment of the support members 130 a, 130 b as best seen inFIGS. 21E and 23.

[0167] Continued downward movement of handle 12 results in both proximalmovement of the second retractor 50 and engagement of the handle lock 40with the handle 12. More particularly and as best illustrated in FIG.22, as the user continues to move the handle 12 in a downward direction,flanges 14 a and 14 b clear corresponding flanges 42 a and 42 b andspring 45 biases handle lock 40 proximally in the direction of referencearrow “D” to lock the handle 12 in position. Simultaneously, cam 60 isrotated about pin 54 to a point where the second stages 64 a and 62 a ofthe cam slots 64 and 62 effect the movement of the cam followers 51 aand 51 b. More particularly, as cam 60 is forced downwardly, the secondstage 62 a of cam slot 62 moves cam follower 51 b proximally which, inturn, moves the second retractor 50 proximally. The second stage 64 a ofcam slot 64 is generally vertically oriented and, as a result, camfollower 51 a moves vertically upon continued downward movement ofhandle 12. Slot 57 of retractor 50 allows the second retractor 50 toslide proximally relative to cam follower 51 a.

[0168] As mentioned above, second retractor 50 moves the key-like end 53of the second retracting sleeve 120 within carriage 86 relative to thefirst retracting sleeve 110 as illustrated by reference arrow “E” ofFIG. 22A. Proximal movement of the second retracting sleeve 120 retractsthe prongs 127 a and 127 b of fingers 124 a, 124 b, respectively, whichreleases the surgical fasteners 260 as illustrated by reference arrow“E” of FIG. 22B.

[0169] It is envisioned that the surgical instrument 10 and/or the SULU100 may need to be manipulated to assure consistent and tactful releaseof the surgical fasteners 260 from the SULU. For example, it iscontemplated that after and/or simultaneously with activation of thehandle 12, the presently disclosed methods described herein may includethe step of manipulating the surgical instrument 10 or SULU 100 relativeto the surgical fasteners 260 to facilitate release thereof, e.g.,rotational or off-axis manipulation relative to axis “A” (See FIG. 5),vertical manipulation, horizontal manipulation, pivotal manipulationand/or any simultaneous or sequential combination of theseaforedescribed manipulative movements.

[0170] Further, it is contemplated that the surgical instrument 10 orthe SULU 100 may be manufactured to include an additional activator,lever, handle, pivot element, linkage or the like (not shown) which uponactivation thereof will manipulate the surgical instrument 10 and/orSULU 100 relative to the surgical fasteners 260 in one of the mannersdescribed above to facilitate consistent and tactful release of thesurgical fasteners 260.

[0171] As mentioned above, after sleeve 110 is retracted, locking sleeve140 a moves proximally to allow the two supports 130 a and 130 b topivot away from one another as shown in FIG. 23 to permit the removal ofthe saphenous vein 320 from within the SULU thereby completing thevascular anastomosis as shown in FIG. 24.

[0172]FIG. 26A shows a schematic diagram of the surgical fastener staplepattern which is formed upon actuation of the instrument described abovewith respect to FIGS. 1-26. More particularly, the surgical fastenersare supported by the fastener support braces 137 a, 137 b in a normalmanner relative to a longitudinal axis “A” (FIG. 5) extending throughthe SULU. It is envisioned that other surgical fastener staple patterns,e.g., spiral, tangential or angular relative to axis “A”, may beutilized to achieve hemostasis between vessels, FIG. 26B. For example,it is contemplated that arranging the surgical fasteners 260 in one ofthe aforedescribed patterns may enable more surgical fasteners 260 to beemployed within the same spatial considerations which may achieve a moreconsistent and/or more reliable hemostasis between vessels.

[0173] It will be understood that various modifications may b made tothe embodiment shown herein. For example, the instrument may be sized toperform an anastomosis for other vessels and luminal tissue. Moreover,although the various internal components of the instrument 10 are shownengaged by particular mechanical interfaces it is envisioned that othertypes of mechanical interfaces can be employed to achieve the same orsimilar purpose, e.g., snap-fit, tongue and groove, press fit, etc.Therefore, the above description should not be construed as limiting,but merely as exemplifications of preferred embodiment. Those skilled inthe art will envision other modifications within the scope and spirit ofthe claims appended hereto.

What is claimed:
 1. An aortic punch for creating an aortotomy in a wallof a luminal structure, comprising: a housing including distal andproximal ends, first and second plungers, a first return spring and acutting assembly; said first plunger being movable relative to saidhousing to expose a barb from said distal end of said housing forpiercing and catching the wall of the luminal structure; said firstreturn spring for biasing said barb proximally toward said distal end ofsaid housing such that said barb pulls the wall of the luminal structureinto contact with said cutting assembly; and said second plunger beingmovable relative to said housing independent of said first plunger torotate said cutting assembly against the wall of the luminal structureto create the aortotomy in the luminal structure.
 2. An aortic punchaccording to claim 1 wherein said second plunger includes a rack whichcooperates with a corresponding pinion disposed on a proximal end ofsaid cutting assembly to rotate said cutting assembly when said secondplunger is moved relative to said housing.
 3. An aortic punch accordingto claim 2 wherein said cutting assembly includes a serrated tip.
 4. Anaortic punch according to claim 3 wherein said cutting assembly includesat least two gears which cooperate with said rack to rotate said cuttingassembly when said second plunger is moved relative to said housing. 5.An aortic punch according to claim 4 wherein at least one of said gearson said cutting assembly is beveled.
 6. An aortic punch according toclaim 1 wherein said second plunger includes a second return spring forbiasing the plunger in a proximal direction.
 7. An aortic punchaccording to claim 1 wherein said first plunger includes a spline forfacilitating rotational movement of said cutting assembly about a distalend of said first plunger.
 8. An aortic punch according to claim 1wherein movement of said second plunger distally moves said cuttingassembly in a first direction and movement of said plunger proximallymoves said cutting assembly in a second direction.
 9. A method offorming an aortotomy in a luminal structure comprising the steps of:providing an aortic punch having a housing which includes: distal andproximal ends, a first plunger having a barb, a first return spring, acutting assembly and a second plunger mechanically engaged with saidcutting assembly; moving said first plunger relative to said housing toexpose said barb from said distal end of said housing piercing the wallof the luminal structure with said barb; releasing said first plungersuch that said first return spring biases said barb proximally towardsaid distal end of said housing to catch the wall of the luminalstructure and pull the wall of the luminal structure into contact withsaid cutting assembly; and moving said second plunger relative to saidhousing independent of said first plunger to rotate said cuttingassembly against the wall of the luminal structure to create theaortotomy in the luminal structure.